This invention relates to woven tubular grafts having selected regions of varying flexibility and particularly to woven bifurcated tubes for use as endoluminal grafts in the treatment of vascular aneurysms.
A vascular aneurysm is a pathologic dilation of a segment of a blood vessel which constitutes a weakened portion of the vessel. FIG. 1 shows an example of a fusiform aneurysm 10, such as can occur in the abdominal aorta 12. The entire circumference of the aorta 12 is dilated and weakened. The majority of these aortic aneurysms are located in the distal abdominal aorta between the renal arteries 14 and the bifurcation point 16 where the abdominal aorta splits into the common iliac arteries 18.
An aneurysm in any vascular vessel is a cause of concern, and aortic aneurysms in particular constitute a serious condition, as an acute rupture of the aneurysm is fatal unless an emergency operation is performed. However, even when such operations are performed in time, the mortality rate is still greater than 50%.
Modern methods of treatment for aneurysms focus on preventing rupture by providing a stent graft which is positioned within the artery at the aneurysm. As seen in FIG. 1 by way of example, a stent graft 20 comprises a bifurcated fabric tube 22. Bifurcated fabric tubes are formed of a plurality of interlaced yarns wherein a single tube branches into two or more tubes at a bifurcation point. The term xe2x80x9cyarnxe2x80x9d as used herein is a generic term for a continuous strand or strands of fibers, filaments or material in a form suitable for knitting, weaving, braiding or otherwise intertwining or interlacing to form a fabric. Various forms of yarn include monofilaments, filaments twisted together, filaments laid together without twist, as well as other configurations.
Tube 22 may be woven, knitted or braided and has one end 24 which is attached to the inner surface of the artery upstream of the aneurysm 10. The opposite end 26 of the bifurcated tube is split at a septum 28 into two branch tubes 26a and 26b. The branch tubes are attached to the inside surfaces of the iliac arteries 18 below the aneurysm 10. The stent graft 20 is substantially impermeable to blood and replaces the abdominal aorta in the region of the aneurysm 10, relieving the pressure on the weakened arterial wall and avoiding a potentially fatal rupture.
For endoluminal stent grafts, which are implanted in the artery through the use of a catheter, woven tubes are preferred because the graft should have as little bulk as possible so that it may be readily collapsible to fit within the lumen of the catheter. As noted above, the graft must also be substantially impermeable in the region of the aneurysm so as to isolate and relieve the pressure on it. Woven structures inherently have relatively minimal bulk when compared to knitted or braided structures having the same dimensions and can readily form a substantially impermeable membrane with low porosity. Because bifurcated grafts, with their multiple tubes, tend to be bulkier than grafts comprising a single tube, the woven structure which minimizes the bulk is especially advantageous.
The advantages of small bulk and low porosity for woven endoluminal grafts are obtained at a significant disadvantage in that the woven tube is generally unable to stretch elastically in either the radial or longitudinal directions. The lack of flexibility is inherent in woven fabrics due to the limited relative motion afforded to the yarns, which are substantially locked in place due to the nature of the weave and the requirement of impermeability. The lack of flexibility results in the disadvantages described below for the example of the woven bifurcated tube used as a graft for the repair of an aortic aneurysm. It is understood that the examples provided below apply to other than bifurcated tubes in the repair of other types of aneurysms as well.
Blood vessels are seldom round in cross-section; they tend to be oval, egg-shaped or have irregular shapes due to calcified deposits formed on the inner walls. The woven bifurcated tube must sealingly join the vessel at both its ends, but the lack of radial flexibility inhibits the ability of the tube to adapt to the non-round cross section of the vessel. As shown in FIG. 2, this may result in folds 30 in either or both the vessel 12 and the tube 22 where they are joined at upstream end. The folds can result in leakage of blood past the graft at its upstream end and into the aneurysm, placing pressure on the aneurysm and possibly causing it to burst.
Blood vessels are seldom straight; they tend to curve in complex ways. This is readily apparent in bifurcated vessels such as the abdominal aorta 12 which in which branches 26a and 26b curve away into the iliac arteries 18 supplying blood to the lower extremities. The lack of longitudinal flexibility inhibits the woven graft from readily bending to follow the curvature of the iliac arteries as they branch away from the aorta. As seen in FIG. 3, the branch 26a of the woven tube 22 may tend to buckle and bunch up on the inside part of the curve, causing folds 32 which can occlude the lumen of the graft, restricting blood flow. The part of the branch 26a on the outside of the curve does not stretch to accommodate the longer path of the artery wall and tends to tug on the artery, perhaps causing a kink 34 in its wall.
Blood vessels tend to vary in diameter from person to person depending on the physical characteristics of the individual. Due to their inherent lack of radial flexibility, woven tubes of one particular diameter cannot readily adapt to the range of artery sizes among different people. As shown in FIG. 4, if the tube 22 is too small in diameter, it may cause folds 36 in the artery 12, reducing the blood flow and causing leaks past the joint. If the tube is too large, it may tend to form an inward fold 38 and leak, as seen in FIG. 5. Therefore, many sizes of grafts must be available so that the appropriate size may be matched to a particular artery size so that a good seal can be obtained between graft and artery.
Blood vessels tend to enlarge in diameter with the age of the patient. The woven tube 22 generally does not have sufficient radial flexibility to accommodate the expansion of the vessel 12 and may result in a separation 40 of a portion of the graft from the wall of the vessel as seen in FIG. 6. This may allow leakage into the aneurysm, and in extreme cases the upstream portion of the tube may fold into the lumen, inhibiting the flow of blood through the vessel.
Woven tubes with little radial or axial elasticity tend to be stiff. This stiffness directly affects the force required to move the stent graft through the lumen of a catheter for positioning the graft within the artery at the aneurysm. The catheter is seldom straight as it must follow the bends and twists of the vessel through which it snakes, and the stiffer the graft is, the more force is required to move it through a twisting catheter lumen.
There is clearly a need for an endoluminal graft which has minimal bulk so that it will fit within the lumen of a catheter, is substantially impermeable and strong enough to withstand repeated hydraulic pressure cycles caused by hundreds of thousands of heart beats and yet possesses the radial and longitudinal flexibility, allowing it to move with minimal force through a curving catheter and to sealingly accommodate arteries of various shapes, sizes and curvatures without folding or kinking in order to form and maintain a fluid-tight seal between the graft and the artery in the treatment of aneurysms.
The invention concerns a graft compatible with living tissue, the graft comprising an elongated tube woven from a plurality of warp yarns oriented in a warp direction substantially lengthwise along the tube and a plurality of fill yarns oriented in a fill direction substantially circumferentially around the tube. The warp and the fill yarns are elastic, and the tube comprises a region of relatively greater flexibility oriented in one of the warp and the fill directions.
The region of relatively greater flexibility is formable in the warp direction by weaving the warp yarns comprising the region under relatively less tension than the tension at which the warp yarns comprising the remainder of the tube are woven. The region of relatively greater flexibility is formable in the fill direction by weaving the fill yarns comprising the region under relatively less tension than the tension at which the fill yarns comprising the remainder of the tube are woven.
It is advantageous to have a region of relatively greater flexibility oriented in the fill direction and located at one end of the tube, the region of relatively greater flexibility being formed by weaving the plurality of the fill yarns comprising the region under relatively less tension than the tension at which the fill yarns comprising the remainder of the tube are woven. Such a tube may also comprise a second region of relatively greater flexibility oriented again in the fill direction and located at an opposite end of the tube, the second region of relatively greater flexibility also being formed by weaving the plurality of the fill yarns comprising the second region under relatively less tension than the tension at which the fill yarns comprising the portion of the tube between the first and second regions are woven.
It is also possible to have a third region of relatively greater flexibility oriented in the warp direction and located between the first and second regions of relatively greater flexibility. The third region of relatively greater flexibility is formed by weaving the plurality of warp yarns comprising the third region under relatively less tension than the tension at which the warp yarns comprising the first and second regions of relatively greater flexibility are woven.
The region of relatively greater flexibility may also be formed in the warp direction by including in the region relatively fewer of the warp yarns per unit area than the number of the warp yarns per unit area comprising the remainder of the tube. Similarly, the region of relatively greater flexibility may also be formed in the fill direction by including in the region relatively fewer of the fill yarns per unit area than the number of the fill yarns per unit area comprising the remainder of the tube.
The invention also includes a method of making a graft comprising an elongated tube compatible with living tissue and having a region of relatively greater flexibility. The method according to the invention comprises the steps of:
(1) weaving a plurality of elastic warp yarns oriented in a warp direction substantially lengthwise along the tube at a first predetermined tension with a plurality of elastic fill yarns oriented in a fill direction substantially circumferentially around the tube at a second predetermined tension; and
(2) weaving at least some of the yarns at a third predetermined tension relatively less than the first and the second tensions thereby forming the region of relatively greater flexibility, the flexibility being greater in the warp direction when the plurality of the warp yarns are woven at the third predetermined tension, the flexibility being greater in the fill direction when the fill yarns are woven at the third predetermined tension.
According to the method, a plurality of fill yarns may be woven at the third tension over a portion of the tube positioned at one end, thereby forming the region of relatively greater flexibility at the one end, the increased flexibility being in the fill direction.
Furthermore, the plurality of fill yarns may also be woven at the third tension over a second portion of the tube positioned at an opposite end thereof, thereby forming a second of the regions of relatively greater flexibility at the opposite end of the tube, the increased flexibility also being in the fill direction at the opposite end.
It is also advantageous to weave the plurality of warp yarns at the third tension over a third portion of the tube positioned between the ends, thereby forming a third region of relatively greater flexibility, the increased flexibility being in the warp direction over the portion between the ends.
It is an object of the invention to provide a woven graft having regions of differing flexibility in the warp and fill directions.
It is an object of the invention to provide a woven graft having relatively greater radial flexibility at its ends for accommodating an irregularly shaped vessel.
It is another object of the invention to provide a woven graft having relatively greater radial flexibility at its ends for accommodating a vessel whose diameter changes over time.
It is still another object of the invention to provide a woven graft having greater flexibility in the warp direction allowing the graft to stretch lengthwise and follow a curved path within a vessel.
It is yet another object of the invention to provide a woven graft having relatively greater flexibility without increasing the bulk of the graft.
It is again another object of the invention to provide a woven graft which will pass through a catheter relatively easily.